JP6861169B2 - Compositions for Weight Loss Containing Beverages and Beads - Google Patents

Description

The present invention relates to beverages and compositions for oral administration that include beads dispersed in the beverage. The present invention also relates to devices for preparing compositions and uses for reducing the weight of an individual.

Overweight and obesity are becoming increasingly problematic in developed and developing countries around the world. It is generally accepted in the medical community that obesity is associated with adverse health effects such as diabetes, heart failure, hypertension and an increased risk of metabolic disorders. There is an ongoing need for means and methods to assist individuals in losing weight or preventing weight gain.

It has been proposed in the art that certain herbs, teas or herbal active substances can support weight loss and control. However, the weight loss that can be achieved with such active substances is often not significant. It has not been generally proven that certain herbs, teas or herbal ingredients significantly mediate weight loss and reduce obesity over time.

In this regard, it has also been proposed that consumption of green tea may help individual weight loss or control. However, the effect appears to be due to a feeling of fullness in the stomach rather than the active ingredients that reduce and control body weight.

Various beverages or foods in which green tea is mixed with ingredients that are said to be effective in weight control have been proposed or are commercially available.

Patent Document 1 discloses a beverage in the form of a health care and health-preserving tea, which is mainly composed of green tea and licorice. The inventors describe that tea has the effect of removing heat, breaking down sputum, losing weight, losing weight, improving eyesight and calming the liver. However, no evidence of such effects has been provided, consistent with the general belief that significant effects on weight loss from the consumption of beverages and foods are difficult to achieve.

Patent Document 2 discloses a green tea beverage containing Jiaogulan (Gynotemma pentaphyllum) and Folium nelumbinis. The inventors claim that the beverage containing the composition has various beneficial effects such as improving immunity, reducing blood lipid levels or weight loss, but evidence of the effects has been provided. Absent.

Patent Document 3 discloses a green tea beverage containing China root (Poria cocos), Dutchmanpipe root and mulberry leaf. The inventors claim that the beverage containing the composition has various beneficial effects such as skin whitening, toxin release or weight loss, or effects on arteriosclerosis, but evidence of the effects is provided. It has not been.

Patent Document 4 relates to sustained release beads that provide an active ingredient such as caffeine for a long period of time after oral administration. It proposes that the beverage contains beads in small amounts, eg 0.1% by weight, which allows them to be easily swallowed and slowly releases the active ingredient in the stomach. It has not been proposed to provide a composition associated with weight loss. In contrast, the beads are dispersed in fructose syrup in the action examples.

Patent Document 5 discloses a pouring composition containing a plurality of flavored gel-like beads dispersed in a continuous aqueous phase. The beads contain 0.3-10 wt%, preferably 0.5-4 wt%, anionic gelled polysaccharide selected from the group consisting of pectin, alginate and mixtures thereof. It is not proposed to provide a composition associated with weight loss. In contrast, liquid feed compositions containing high levels of sucrose and glucose syrup are disclosed in the Examples of Action.

Given the above issues, there is an ongoing need for providing means such as beverages or foods to lose and control an individual's weight.

Chinese Patent No. 103891935A Chinese Patent No. 101658221A Chinese Patent No. 104247801A U.S. Patent Application Publication No. 2010/0330189A1 European Patent No. 1629722A1

A fundamental problem of the present invention is to provide a composition for oral consumption for reducing the body weight of an individual. The composition is intended to support an individual's desire to lose weight, prevent weight gain, or control his / her weight. The flavor and overall appearance of the composition should be comfortable or at least acceptable to the individual. The mode of consumption or administration should be easy and convenient. The composition should be readily available at a relatively low cost. Overall, the composition must be applicable for long-term consumption at regular intervals or time points.

Surprisingly, it has been found that the fundamental problems of the present invention are overcome by the composition, equipment and use according to the claims. Further embodiments of the present invention are described throughout the detailed description.

The subject of the present invention is a beverage and a composition for oral administration containing beads dispersed in a beverage, the beads having an average diameter of 2 to 10 mm, and the beads having a dietary fiber of more than 50% (w / w). The composition is such that the amount of beads in the composition is 1 to 20 wt%.

The composition is for oral administration. Specifically, the composition is applicable to beverages in combination with eating beads. The beads are chewed during or during the drinking process. This is possible because the relatively small beads are dispersed in the beverage. When the composition is drunk, the beads are ingested while drinking and can be chewed during or during the drinking.

Overall, compositions and beads composed primarily of dietary fiber have a relatively low energy content. It has been found that consumption of such low energy compositions by drinking in combination with chewing beads has a significant effect on weight loss. The composition was found to reduce hunger or appetite and its effect lasted for a long time. The effect appears to correlate with epigenetic factors. Beverages are known in the art to be able to relieve hunger for a short period of time. This is because gastric filling associated with gastric distension activates mechanical receptors in the stomach, thereby temporarily suppressing the feeling of hunger. However, this effect is only for a short time and has no significant effect on weight loss. In addition, the chewing process is known to affect mechanical receptors in the mouth, nose and pharyngeal areas, which also temporarily suppress hunger or appetite. Also, this effect is short-lived and is generally not considered to have a significant effect on weight loss, as observed, for example, when chewing and consuming gum. However, the combined effect of filling and chewing the stomach achieved with this composition with a specifically designed low energy content induces weight loss significantly and permanently, or gains weight. Was found to prevent. Therefore, the composition is associated with unpredictable synergies from the isolated components.

The composition comprises beads dispersed in the beverage. The beads are solid. They maintain their shape and texture in the beverage at least for the duration of consumption of the composition. Preferably, the beads are water repellent. This indicates that the beverage does not penetrate inside the beads and / or the beads do not soak or dissolve in the beverage for at least the period required for consumption. For example, the beads should be stable and / or water repellent in the beverage for at least 20 minutes, preferably up to 30 minutes, up to 40 minutes, up to 1 hour or up to 5 hours. Preferably the beads are not gels.

The beads have an average diameter of 2-10 mm, preferably 3-6 mm or 4-5 mm. Preferably, all of the beads have a diameter of 2-10 mm, preferably 3-6 mm or 4-5 mm. When the beads are smaller than 2 mm, chewing is no longer convenient for consumers and they tend to be swallowed. When the average diameter is greater than 10 mm, they may be too large to be consumed when drinking in the desired amount and to be conveniently and evenly chewed. We have found that the optimal bead diameter for chewing in combination with drinking is 4-5 mm. The diameter is determined by the maximum diameter of the beads. The bead diameter may be adjusted during the manufacturing process, for example if the beads are manufactured by compression in the mold. If the beads are not of a given size, the average bead diameter can be determined by visual analysis, preferably by measuring and averaging the maximum diameter of a significant number of beads, such as 100, 500 or 1000 beads. ..

The beads may have any shape that is applicable for ingestion with beverages by drinking and chewing. The shape is preferably circular, for example spherical or elliptical. Preferably the beads are spherical. Alternatively, they may have other typical shapes known from the manufacture of dragees, tablets, pellets and the like.

The amount of beads in the composition is 1-20 wt%, preferably 2-15 wt% or 4-10 wt%. Overall, the beverage-to-bead ratio should be adjusted so that the overall drinking and chewing time is similar, i.e., the bead can be conveniently chewed while the individual is drinking the beverage. is there. In general, a large excess (w / w) beverage is required to achieve a good balance between drinking the beverage and chewing the beads. Considering excess beverages, the drinking process is usually faster than the chewing process.

The effect of the composition for weight loss is supported by the relatively low dietary energy content of the composition. Therefore, individuals consuming the composition do not consume large amounts of food energy that contradicts the purpose of weight loss.

Dietary fiber is the main component of beads. Therefore, the beads contain more than 50% (w / w) dietary fiber. Preferably, they contain more than 60%, more than 70%, or even more than 80%, or more than 85%, or more than 90% (w / w) dietary fiber. Preferably, the amount of dietary fiber is 50% to 98%, more preferably 80% to 95% (w / w).

As used herein, the term "dietary fiber" refers to food-applicable carbohydrates that are difficult to digest in humans, as well as lignin. Specifically, dietary fiber is preferably a carbohydrate polymer (polysaccharide) having at least 10 monomeric units, which is not hydrolyzed by endogenous enzymes in the human small intestine. Since such fibers cannot be digested by intestinal enzymes, energy cannot be used by the individual and the food energy content is low. Preferably, the dietary fiber is a carbohydrate or a derivative thereof. As used herein, the term "derivative" refers to chemically modified carbohydrates that are generally accepted or useful in the food industry. The fiber may preferably be plant-derived natural, artificial, or treated natural fiber. The term "dietary fiber" includes "functional fiber". In a preferred embodiment, the fiber is a natural fiber and / or a derivative of the natural fiber. Preferably, dietary fiber is approved as a food ingredient in the European Community or the United States. Dietary fiber may be cellulose, alginic acid, arabinoxylan, inulin, chitin, pectin, resistant starch, resistant dextrin, and beta-glucan, or derivatives thereof.

In a preferred embodiment, the beads contain dietary fiber obtained from seaweeds (algae), such as polymer electrolytes such as agar, alginic acid, sodium alginate or carrageenan, or derivatives thereof. The seaweed-derived fibers may be from Eucheuma, Gigartina and / or Chondrus. The fibers may also be polymer electrolytes such as natural rubber obtained from plants, such as gum arabic or derivatives thereof.

Preferably, the polysaccharide derivative is an ether, preferably a C1-C5 alkyl ether, more preferably a methyl, ethyl or propyl ether; or an ester, preferably a C1-C20 carboxylic acid, more preferably an acetate ester; or 1-5. It is substituted with a carboxylalkyl group having C atoms, preferably a carboxymethyl group. Polysaccharide derivatives applicable as food additives are well known in the art. For example, they are described in "Food Polysaccharides and Their Applications", Alistair M. et al. Stephen, Glyn O. et al. Phillips, 2006 CRC Press.

In a preferred embodiment, dietary fiber is not fermentable in humans. In this context, the term "fermentable" means that dietary fiber is not digested by gut microbiota. Specifically, carbohydrate chains are typically not cleaved. Non-fermented dietary fiber has a very low dietary energy content.

In a preferred embodiment, dietary fiber is cellulose fiber or a derivative thereof. Typically, cellulose and its derivatives are not digested by intestinal enzymes and are not fermented by gut microbiota. Therefore, the food energy content of cellulose and its derivatives is actually approximately 0 kJ / mol. As used herein, the term "cellulose derivative" refers to cellulose that has been modified by a chemical reaction and is applicable to food and / or approved for use in food. Preferably, the derivative is a cellulose ether, preferably a C1-C5 alkyl ether, more preferably a methyl, ethyl or propyl ether; or an ester, preferably a C1-C20 carboxylic acid ester, more preferably an acetate ester; or 1- It is substituted with a carboxyalkyl group having 5 C atoms, preferably a carboxymethyl group. The cellulose ether and / or ester may be substituted with 1, 2 or 3 hydroxyl groups in the glucose ring unit. Preferably, the cellulose derivative is selected from methyl cellulose (MC), hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), carboxymethyl cellulose (CMC), ethyl methyl cellulose (MEC) or microcrystalline cellulose (MCC). Cellulose derivatives applicable as food additives, especially cellulose ethers, are well known in the art. For example, they are described in "Cellulose and Cellulose Derivatives in the Food Industry: Fundamentals and Applications", 2015, Wiley-VCH Verlag GmbH & Co., Ltd. It is described in KGaA, Tanja Wustenberg (editor). Preferably, the derivative is approved for use in food in the European Community or the United States on the priority date of this application.

The beads have a low energy content. Preferably, the energy content of the beads is 500 kJ / 100 g or less, preferably 400 kJ / 100 g or less, more preferably 300 kJ / 100 g or less, more preferably 200 kJ / 100 g or less, or even 150 kJ / 100 g or less. Such low energy content may be adjusted by including a high proportion of non-fermentable dietary fiber.

According to this application, the energy content of the beads is determined by a standard energy table for the main food ingredients: fat (37 kJ / g), ethanol (29 kJ / g), protein (17 kJ / g), carbohydrates. (17 kJ / g), organic acid (13 kJ / g), polyol (10 kJ / g) and dietary fiber (8 kJ / g), which, by modification, contain the energy of non-digestible and non-fermentable fibers such as cellulose derivatives. The amount is set to 0 kJ / g. The energy content of other unknown components can be determined by the amount of heat.

Beverages (without beads) should have a relatively low energy content. Preferably, the energy content of the beverage (without beads) is 25 kJ / 100 g or less, preferably 10 kJ / 100 g or less, 5 kJ / 100 g or less, or even 2 kJ / 100 g or less, or approximately 0 kJ / 100 g. Such low energy content can be achieved with water, tea or diluted juice. The energy content of the beverage can be calculated for the beads as described above. Alternatively, the energy content of the beverage can be determined by the amount of heat.

The energy content of the composition may be 100 kJ / 100 g or less, preferably 50 kJ / 100 g or less or 25 kJ / 100 g or less, more preferably 20 kJ / 100 g or less, or even 15 kJ / 100 g or less or 10 kg / 100 g or less. Such low energy content can be achieved with beads and low energy beverages as described above.

The low energy content of compositions, beads and beverages is beneficial in reducing food energy intake when the composition is consumed. Therefore, the energy content of the composition supports the beneficial effect of the composition on weight loss achieved by drinking and chewing. It lowers overall energy intake, but can suppress hunger or appetite.

Beverages may be selected from water such as mineral water, tea, diluted juices or low energy soft drinks. In a preferred embodiment, the beverage is a natural beverage. Preferably it is tea, more preferably green tea. Green tea has a variety of beneficial properties. The energy content is very low as it is about 2kJ / 100g. Green tea is generally recommended in the art to reduce temporary appetite. In addition, it appears to contain active substances that can prevent obesity. Green tea is also generally accepted by individuals who want to increase their health and well-being. Therefore, green tea can support the beneficial effects of this composition.

In a preferred embodiment, the beads contain at least one plant active substance such as plant sterols, saponins, glycyrrhizins, liquiritins, liquiritigenins, oterins, orthosiphons or bromelains. Preferably, the plant active substance is preferably provided in the form of a plant extract. Preferably, the plant extract contains active substances and / or is free of plant energy-rich components such as proteins, lipids and carbohydrates. In a preferred embodiment, the plants are licorice (Glycyrrhiza grabra), bitter orange (Citrus aurantium) (cinefrin), natural yam (Dioscorea vilosa), centella asiatica (Centella asiatica), Centella asiatica (Centella asiatica), Centella asiatica (Centella asiatica) And ginkgo, or fruits and vegetables, preferably pineapple (bromeline), mango or papaya.

In a preferred embodiment, the plant active substance supports weight loss. In a preferred embodiment, the beads comprise an extract from licorice, preferably rich in glycyrrhizin. Since the active ingredient glycyrrhizin can have a positive effect on weight loss, the effect of the composition can be supported.

In a preferred embodiment, the composition is free of sugars for sweetening, i.e. saccharide sweeteners. Preferably, such sugar sweeteners are not included as additives. Preferably, the composition is free of monosaccharides and / or disaccharides. Preferably, it is free of glucose, lactose or fructose. This means that there are no significant amounts of monosaccharides. A small amount may be present in the composition. Because they are contained in additives such as extracts from natural sources such as licorice. Preferably, the composition is a sugar selected from monosaccharides and disaccharides of less than 1% (w / w), preferably less than 0.5% (w / w) or less than 0.2% (w / w). including. Preferably, the beads and / or beverage are less than 1% (w / w), preferably less than 0.5% (w / w), or less than 0.2% (w / w), monosaccharides and disaccharides. Contains sugars selected from. Additives should be selected so as not to significantly increase the energy content of the composition, i.e. not detrimental to the desired effect on weight loss. Additives that do not have a low energy content, if any, should be added only in small amounts. Additives should be selected so that the overall energy content remains low. Low molecular weight saccharides, especially monosaccharides and disaccharides, have high energy content and should be avoided. Preferably, the composition and / or beads are sweetened with other sweeteners such as stevia.

In a preferred embodiment, the beads, preferably in combination with green tea as a beverage, contain a cellulose derivative, in particular at least 70% dietary fiber which is methyl cellulose and / or hydroxypropyl methyl cellulose, and licorice extract. In a preferred embodiment, the beverage is green tea and the beads contain glycyrrhizin and methylcellulose and / or hydroxypropylmethylcellulose. Glycyrridine and green tea can have a positive effect on weight loss and thus can support the effect of the composition, while cellulose derivatives are particularly applicable as low energy polymers.

In a preferred embodiment, the beads contain at least one additional additive that is not dietary fiber or a plant active substance. In principle, any additive applicable in the art of making sugar-coated tablets, food pellets or tablets may be used. When used in large quantities, the additive should have an appropriate energy content. Additives can give the beads the desired properties or can improve the production and stability of the beads. Preferably, the additives are sweeteners such as stevia, binders, coatings, food supplements such as chromium polynicotinate, anticaking agents, colorants, disintegrants, flavors, flow promoters, lubricants. , Preservatives, adsorbents and hydrophobic substances. Sweeteners, flavors, colorants, plant extracts and the like can be easily mixed with dietary fiber to provide a pleasant taste and appearance to the composition. This is beneficial to support regular consumption by individuals over a long period of time.

In a preferred embodiment, the beads are water repellent. This means that the water in contact with the beads will drip from the beads and / or will not penetrate the beads. For example, the additive can make the beads water repellent. Preferably, they are hydrophobic substances such as lipids, fats and / or waxes, preferably esters from mono- and diglyceride fatty acid esters, especially tartrate acids. Alternatively, the beads may be coated with a water repellent coating. The beads may contain any known coating used in food or tablet technology. Preferably, the coating comprises a polymer, especially a polysaccharide, such as a cellulose derivative, such as hypromellose-phthalate (HPMC-P), or shellac. The coating may be applied by a known method such as spray coating.

Beads can be produced by a technical process known from the food or pharmaceutical industry for producing similar small beads such as dragees, tablets, pellets, chewing gum and the like. Beads can be produced by compressing the ingredients. In many cases, dietary fiber polysaccharides, the main component of beads, can be compressed into relatively stable beads. The compression and stability of the beads can be improved by the moisture in the formulation. If necessary, a binder may be added to improve the internal strength of the beads. Some dietary fibers, such as methylcellulose, can also function as binders.

If desired, additives such as flavors, colorants or active substances may also be included in the beverage. In a preferred embodiment, the composition comprises epigallocatechin gallate, which is an active substance from green tea.

As a rule, beads are adapted so that they are bitten within about 10-200 seconds, preferably about 20-90 seconds, often within about 30-60 seconds. Therefore, the chewing process requires a lot of effort compared to most regular foods, which is beneficial in reducing overall energy intake.

Another subject of the present invention is a device (system) for storing and / or preparing a composition for oral administration, which comprises a beverage and beads for dispersion in the beverage as described above. .. The bead-to-beverage ratio in the device is adapted such that the composition contains 1-20 w% of beads when all of the beads in the device are mixed with the beverage in the device. Therefore, the composition of the present invention is obtained when all the beads are mixed with the beverage in the apparatus. Preferably, the composition is free of monosaccharides. This means that neither beads nor beverages contain monosaccharides. The device includes a container in which the beverage and beads are kept separate from each other. Preferably, the containers are adjacent to each other.

Such devices (systems) may be provided to consumers who can mix the beverage with the beads before consumption. Thereby, the texture and properties of the beads can be maintained for a long period of time. In a preferred embodiment, the device is a drinking beverage container, such as a cup or bottle, having a compartment containing beads attached to the compartment. Preferably, the device comprises removable means for separating the beads from the beverage. For example, the beads may be embedded in a compartment above the cup that is separated from the beverage by a thin barrier such as paper or film. The device may include a drinking aid such as a straw. The straw has a sufficient width for ingesting beverages and beads through the straw. It has been found that normal consumption of such beverages is possible with straws without any problems with swallowing beads. The device may be adapted so that when the straw enters the beverage, the barrier between the beverage and the beads is broken so that the beads are released into the beverage. Preferably, the device comprises 200-1000 ml of beverage, preferably 250-750 or 200-500 ml.

Another subject of the invention is the use of the above compositions or devices to reduce and / or prevent weight gain of an individual. In one embodiment, the use may be non-therapeutic. Alternatively, the use may be therapeutic, eg, to treat and / or prevent obesity. The composition is then pharmaceutical. The present invention also relates to a method for reducing and / or preventing weight gain of an individual, comprising the step of administering the composition to the individual.

In a preferred embodiment, the use is for a total consumption of 200-2000 ml, preferably 200-1000 ml, or 200-600 ml per day and / or 1-5 times per day, preferably once or twice per day. Is for consumption. Preferably, the use is for long-term consumption, preferably for at least 10, 20 or 50 days. Preferably, the use is for consumption in the evening or evening, eg after 4 pm or after 6 pm. In certain embodiments, use is preferably for consumption by women over 40 or over 50 years of age. In certain embodiments, the consumer is experiencing weight gain prior to administration.

In another embodiment, use is for women during or after menopause. Preferably, those women are experiencing weight gain during or after menopause.

In a preferred embodiment, use is combined with a meal. In this case, the use is to support the diet. Therefore, the composition is consumed, but the overall dietary energy intake is reduced. Specifically, its use is to support dietary restraint after consumption. Preferably, after consuming the composition, the individual consumes no more food on the same day. It has been found that it is easier for an individual to cut off food after consuming the composition than if not consuming the composition.

Preferably, the dosage of the composition is consumed for a time of 10 to 30 minutes, preferably about 15 minutes. The amount of beads in the composition should be adjusted so that sufficient beads are utilized for continuous chewing throughout this time.

As mentioned above, the beads are used to prepare a composition for oral administration or the above apparatus. Preferably, the beads are in an amount of a plurality of beads, eg at least 5 g or at least 10 g.

In a preferred embodiment, the beads are not sustained release beads and are not specifically disclosed in US Patent Application Publication No. 2010/330189A1. Since the beads are chewed and their effect on weight loss depends on the active substance contained, it is not necessary to design the beads so that the active substance is released slowly. In certain embodiments, the beads are free of active ingredients for weight loss. Although not bound by theory, it is assumed that the effect of the composition may be due to the physical combination of the beverage and the chewable beads. In a preferred embodiment, the beverage is free of thickeners.

An exemplary embodiment of the invention and aspects of the invention are shown in the figure.

The beads for use in the composition are shown. Shows the composition in which the beads are dispersed in the beverage.

In FIG. 1, beneficial and typical embodiments of beads are shown. The beads have a normal spherical size and an average diameter of about 4-5 mm. This size is suitable for absorbing beads while drinking or sucking beads with a beverage with a straw. The uniform and smooth surface is comfortable for the consumer.

FIG. 2 shows the composition of the present invention having beads dispersed in a beverage. Beads are heavier than beverages and accumulate at the bottom of the cup. However, the beads can also be interpreted as floating in or on the beverage, for example if the beads are porous, by adjusting the contents appropriately. Accumulation at the bottom of the beverage is beneficial for sucking with a straw.

The compositions of the present invention solve the fundamental problems of the present invention. A significant effect on weight loss was observed in attempts by individuals to consume the composition over an extended period of time. Furthermore, they have found that the composition has an epigenetic effect at the physiological level. Physiological markers have been found that control and influence obesity body weight. Specifically, it has been found that administration of the composition, usually over several weeks, reduces the level of proneurotensin in the blood. Proneurosin is a known biomarker for body weight control. Neurotensin levels are significantly determined by animal fats and sugars. Thus, reduced proneurtensin levels in the blood provide evidence that the compositions of the invention have an epigenetic effect on consumers.

Therefore, the composition provides a novel and informative method for weight loss in an individual. The technique is special for the purpose combination of physical filling of the stomach and activation of mechanical receptors in the area of the mouth by chewing, with beads and compositions specifically adapted. The composition may vary widely in flavor and appearance, which can be user-friendly. Chewing beads can also be comfortable for the consumer, which can be similar to chewing gum consumption. In addition, active ingredients that support appetite loss and weight loss may be included.

Example 1: Preparation of beads Beads were prepared based on various dietary fibers as the main component. Dietary fiber was mostly methylcellulose and hydroxypropylmethylcellulose. In addition, fibers from seaweeds such as Eucheuma, Gigartina and Chondrus were included. Such dietary fibers are known and commonly used in food technology. Stevia was included as a sweetener. Various botanical extracts that have been described in the art as having a pleasant flavor or appearance or improving consumer satisfaction were included. They contained plant active substances such as glycyrrhizin, phytosterols, saponins, isoliquiritigenin and isoliquiritigenin. Natural yam contains a large amount of steroidal saponins. Licorice (Glycyrrhiza grabra) (licorice) extract is rich in active ingredients such as glycyrrhizin, phytosterols, saponins, liquiritin and liquiritigenin. As an example, beads were prepared using the following basic formulation:
Formulation A: Methyl cellulose, hydroxypropyl methyl cellulose, algae mixture (Kirinsai, Suginori, Tsunomata), Stevia, licorice extract, pineapple extract (Bromelain), Daidai (cinefurin) extract.
Formulation B: Methyl cellulose, hydroxypropyl methyl cellulose, algae mixture (Kirinsai, Suginori, Chondrus), stevia, wild yam extract, licorice extract.
Formulation C: Methyl cellulose, hydroxypropyl methyl cellulose, algae mixture (Kirinsai, Suginori, Chondrus), Stevia, Licorice extract, Chromium polynicotinate, Numahakka extract.
Formulation D: Methyl cellulose, hydroxypropyl methyl cellulose, algae mixture (Eucheuma, Suginori, Chondrus), Stevia, Licorice extract.

Additional additives may be included in the formulation to give the beads the desired physical properties. Lipids such as tartrate ester of fatty acid glyceride were added as a binder to make the beads water repellent. The ingredients were mixed, kneaded and compressed into spherical beads. The beads were coated with hypromellose phthalate (HPMC-P) by spray coating to protect and increase the water repellency. Formulation E with all additives is shown in Table 1.

The spherical beads had a diameter of about 4-5 mm (Fig. 1). The dietary energy content of 20 g of beads for a typical single dose was determined to be 25 kJ (corresponding to 125 kJ / 100 g beads; based on the energy content of 0 kJ / 100 g of non-fermentable cellulose derivative). When you start chewing the beads, the texture is slightly elastic, roughly comparable to chewing gum. It took about 30-60 seconds to chew the beads in the mouth.

Example 2: Preparation of Composition Green tea containing about 20 mg ± 5% epigallocatechin gallate per serving (300 ml) was used as a beverage for preparing the composition. 20 g of beads prepared according to Example 1 was poured into 300 g of cold green tea. The beads are water repellent and can be dispersed in tea. The beads sank to the bottom of the cup as shown in FIG. The beads did not soften or change their texture and dissolved within about 40 minutes after contact with water. It took about 120 minutes for the beads to completely dissolve. Since the beads are chewed, they take longer to drink than regular beverages without beads. It took about 5-20 minutes to drink 300 g of green tea, typically with 20 g of beads. The energy content of the present invention and some comparative compositions are summarized in Table 2 below.

The results demonstrate that the energy content of beads and compositions is very low, especially when compared to commercial green tea beverages or natural products.

Example 3: Effect of composition The composition was administered to an individual to evaluate its effect on body weight and epigenetic factors. Trials were performed with the composition described in Example 2 based on 20 g of beads of Composition D containing 300 ml of green tea and 850 mg of stevia and 100 mg of licorice. The composition was administered to 7 individuals once daily for a period of 40-51 days. The individual was a 51-54 year old female who had previously experienced 4-9 kg weight gain since menopause and had not received hormone therapy. Individuals are 4p. Daily. m. Attempts to lose weight in the past by later fasting were unsuccessful. Therefore, they are 4p. m. I agreed to try the composition once later. The subject was 4p. Depending on the feeling of hunger. m. The later dosing time could be selected. In addition, the individual is 4p. m. I fasted later. Subjects were instructed to slowly consume 500 ml of green tea over 15 minutes. At the same time, the subject chewed the beads. Subjects were instructed to consume many beads, which are usually suitable for chewing, prolong chewing for as long as possible, and at the same time drink green tea.

As a result, 5 of the 7 subjects were able to consume the composition daily under certain conditions. The two patients were able to consume the composition only 2-5 times per week under the prescribed conditions. A summary of the conditions and results is provided in the table below. Weight loss of 500 g to 1 kg / week was observed in 5 subjects who consumed the composition daily. All women reported that consumption of the composition under certain conditions significantly reduced hunger. Thus, women were able to continue consuming for extended periods of time, although fasting after 4 pm had previously failed without the compositions of the invention. No side effects such as stomach pain or dyspepsia were observed. The total weight loss observed was 2.4-5.1 kg for all subjects, averaging 3.9 kg. A summary of the conditions and results is provided in Table 3.

To assess the effect on physiological levels, proneurosin levels were determined from the blood of the subject at the beginning and end of the trial. Proneurosin is a known biomarker for body weight control. Neurotensin is formed in the N cells of the small intestine and in the central nervous system. Neurotensin levels are highly affected by animal fats and sugars. With daily administration of the composition, proneurosin levels can be reduced to an average of 13 pm / l for all subjects, which is approximately 10%. The results are also summarized in Table 3.

Overall, this result demonstrates a significant effect of administration of the composition on weight loss for all subjects who participated in the trial, which cannot be easily achieved by fasting.

Example 4: Effect of Comparative Composition Without Beads Further trials were performed to rule out that the positive results of Example 3 were obtained due to the active ingredient in the composition. An equivalent formulation F having the active ingredient of composition D of Example 3 was prepared. However, the composition was not provided in the form of a beverage with chewable beads. In fact, Formulation F was a drinkable beverage prepared by dissolving the ingredients in green tea.

Formulation F (32 kJ / 500 ml):
500 ml of green tea contained 100 mg of licorice, 850 mg of stevia, and 35 g of algae mixture (Eucheuma, Suginori, Chondrus).

Individuals consumed Formulation F once daily for a period of 40-49 days. The individuals were 11 women aged 51-54 years, who had previously experienced weight gain of 4-9 kg since menopause and had not received hormone therapy. Individuals are 4p. Daily. m. Attempts to lose weight in the past by later fasting were unsuccessful. Therefore, they are 4p. m. Later, he agreed to drink 500 ml of Formulation F once a day. The subject was 4p. Depending on the feeling of hunger. m. The dosing time could be selected later. In addition, the individual is 4p. m. I fasted later. Subjects were instructed to slowly consume 500 ml of Formulation F over 15 minutes.

The results are summarized in Table 4 below. An average weight gain of 0.3 kg was observed for the individual. Other than that, no significant changes in other body markers were observed. There were no significant changes in proneurotensin levels.

The results demonstrate that simply drinking green tea with dissolved dietary fiber and licorice, stevia and algae does not stimulate weight loss and does not improve neurotensin (proneurosin) levels. Both Example 3 and Comparative Example 4 provide evidence that the effects of the compositions of the invention on weight loss and proneurotensin levels are caused by the dosage form as a beverage containing chewable beads.

Claims (14)

A composition for oral administration comprising a beverage and beads dispersed in the beverage, said beads having an average diameter of 2-10 mm and containing more than 50% (w / w) dietary fiber. The amount of the beads in the object is 1 to 20 wt%,
The energy content of the composition is 100 kJ / 100 g or less.
Composition. The composition according to claim 1, wherein the dietary fiber is a cellulose fiber or a derivative thereof. The composition according to claim 1 or 2, wherein the dietary fiber is not fermentable in humans. The composition according to any one of claims 1 to 3, wherein the energy content of the beads is 500 kJ / 100 g or less. The composition according to any one of claims 1 to 4, wherein the beverage without beads contains less than 1% (w / w) of carbohydrates. The composition according to any one of claims 1 to 5, wherein the beverage is green tea. The composition according to any one of claims 1 to 6, wherein the energy content of the composition is 50 kJ / 100 g or less. The beads contain at least one plant extract and / or plant active substance, and the plants include licorice (Glycyrrhiza grabula), bitter orange (cinefrin), natural yam (Dioscorea vilosa), and numahaka (Ginkgo biloba). The composition according to any one of claims 1 to 7, selected from aquatic, centella asiatica and ginkgo, or fruits and vegetables. The beads contain at least one additive, which is a sweetener, food supplement, anticaking agent, binder, coating, colorant, disintegrant, flavoring agent, flow promoter, lubricant, preservative. , The composition according to any one of claims 1 to 8, which is selected from an adsorbent and a hydrophobic substance. The composition according to any one of claims 1 to 9, wherein the beverage is green tea and the beads contain methyl cellulose and / or hydroxypropyl methyl cellulose and glycyrrhizin. The composition according to any one of claims 1 to 10, wherein the beads are circular and / or the beads include a coating and / or the beads are water repellent. The composition according to any one of claims 1 to 11, wherein the composition contains less than 1% (w / w) of sugar selected from monosaccharides and disaccharides. An apparatus for storing and / or preparing the composition according to any one of claims 1 to 12, wherein the apparatus comprises a beverage and beads for dispersion in the beverage. Containing a container in which the beverage and the beads are maintained separately, the beverage and the beads are defined in any one of claims 1-12, the beverage and the beads are maintained in separate containers adjacent to each other. The proportion of the beads to the beverage in the apparatus is adapted such that the composition contains 1-20 wt% of beads when all of the beads are mixed in the beverage. Use of beads as defined in any one of claims 1-12 for preparing the composition or apparatus for oral administration according to any one of claims 1-13.

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